Related Practices

Pharmacies are the last line of defense in DEA matters, and have increasingly come under the scrutiny of FDA and state boards given increased attention to drug supply security and safety of compounded drug products

Pharmacies routinely face federal and state regulatory issues. HPM regularly advises compounding pharmacies and outsourcing facilities on compliance with the Drug Quality and Security Act. It assists with pharmacy inspections and responding to both federal and state compliance issues (board complaints, form 483s, warning letters and drug recalls). HPM has experience providing legal advice to pharmacies on compliance with state license requirements, including providing advice and assistance in obtaining and maintaining licenses. It also routinely appears before state boards on licensing and enforcement matters. If pharmacies handle controlled substances, HPM can assist in the controlled substance registration process, respond to questions dealing with handling of controlled substances defending pharmacies before DEA and federal law enforcement entities.